Supplier Quality Engineer

2 days ago


Pune, Maharashtra, India Thompsons Hr Consulting Full time

Purpose

The Supplier Quality Engineer will be responsible for end-to-end supplier quality activities, including APQP execution, process validation (IQ/OQ/PQ/TMV), PV testing, data analysis, and support for manufacturing line design (MLD) changes.

The role ensures supplier compliance with Quality Management System (QMS), medical device regulations, and global quality standards.

Key Responsibilities

APQP & Supplier Readiness

  • Execute APQP activities including Specification Review, Product Quality Planning (PQP), PFMEA, Process Flow Diagrams, and Control Plans.
  • Drive PSW closure and support First Article Inspection (FAI) reviews.
  • Coach and support suppliers on APQP, validation readiness, and Good Documentation Practices (GDP).

Process Validation & PV Execution

  • Lead and support execution of Process Validation activities (IQ/OQ/PQ/TMV) at supplier sites.
  • Develop, review, and approve validation protocols and reports.
  • Ensure timely closure of deviations, non-conformances, and CAPAs arising from validation activities.

Testing, Data Analysis & Capability

  • Perform and review statistical analyses including MSA, GR&R, TMV, and process capability studies.
  • Analyze PV data to assess process robustness and drive continuous improvement.
  • Support process capability enhancements and risk mitigation initiatives.

MLD & Change Support

  • Support Manufacturing Line Design (MLD) modifications and supplier process changes.
  • Update PFMEA, Process Flow, and Control Plans to reflect changes and validation outcomes.

Documentation & Compliance

  • Release and manage all APQP, validation, and quality deliverables in Windchill with accurate metadata.
  • Maintain documentation in compliance with QMS, ISO 13485, and 21 CFR 820 requirements.
  • Ensure traceability, audit readiness, and adherence to regulatory and internal quality standards.

Experience

  • 58 years of experience in Supplier Quality, Manufacturing Quality, or Process Validation roles.
  • Prior experience in medical devices or regulated industries strongly preferred.
  • Strong hands-on knowledge of APQP, PPAP, PFMEA, IQ/OQ/PQ, TMV, MSA, and GR&R.
  • Proven experience working directly with suppliers and managing validations at supplier sites.
  • Solid understanding of ISO 13485, FDA 21 CFR 820, and quality system requirements.
  • Strong technical documentation, analytical, and stakeholder communication skills.

Interested candidates can share their updated resume to



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